Argyle 8888414011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521004665), received between Apr 26, 2018 and May 23, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2023Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT'S PERITONEAL DIALYSIS (PD) CATHETER WAS NOT FUNCTIONING CORRECTLY AND WAS TAKEN TO THE OPERATING ROOM (OR) FOR A REVISION SURGERY ONE MONTH FOLLOWING INITIAL INSERTION (ORIGINAL INSERTION DATE: (B)(6) 2023). THE SURGEON FOUND THAT THE CATHETER WAS FRACTURED AND LEAKING INTERNALLY AT THE INSERTION SEGMENT OF THE CATHETER ABOVE THE MISSOURI BEADED CUFF. THE ETERNAL SEGMENT OF THE CATHETER WAS NORMAL AND HAD NO DEFECTS. THERE WAS NOTHING UNUSUAL OBSERVED AT THE TIME OF INSERTION. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS NORMAL. THE CLEANING AGENTS WAS NOT SWITCHED OVER THE LIFE OF THE CATHETER. THE CLEANING AGENTS WAS NOT MIXED. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THERE WAS NO PROTOCOL CHANGE FOR THE CLEANING AGENTS USED RECENTLY. FOLLOWING INITIAL INSERTION STERILE GAUZE WITH TEGADERM WAS UTILIZED AND NO DRESSING WAS USED AFTER 2 WEEKS FOLLOWING HEALING. THE WOUND DRESSING DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE PATIENT WAS RESP ONSIBLE FOR KEEP

  Patient problems: Insufficient Information

  MAUDE report 16988870 ↗
• InjurySep 25, 2020Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, THE CATHETER BROKE AT THE COUPLING PIECE. IT WAS MENTIONED THAT IT WAS UNKNOWN HOW THE BREAK HAPPENED. IT WAS ALSO MENTIONED THAT NO CLEANING NOR DISINFECTION, PATIENT DID NOT SHOWER. IT WAS STATED THAT THE LEAK/BREAK WAS INTERNAL. IT WAS ALSO STATED THAT COMPUTED TOMOGRAPHY(CT) SCANS HAD BEEN MADE TO IDENTIFY THE BROKEN CATHETER. THE SURGEON ASSURED THAT A REPAIR KIT WILL BE ENOUGH TO REPAIR THE BROKEN DEVICE. IT WAS STATED THAT THERE WAS A LEAK AT THE JUNCTION OF EXTENSION TUBE AND BIFURCATE. TEGO WAS NOT USED. THERE WAS NO LUER ADAPTER ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 10590493 ↗
• InjuryApr 26, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER WOULD FILL DIALYSATE, BUT WOULD NOT DRAIN. THE PATIENT WAS SENT IN FOR REPAIR, BUT THE CATHETER BROKE OFF AND WAS FOUND FLOATING IN THE ABDOMEN. THE CATHETER WAS REMOVED LAPAROSCOPICALLY AND IT WAS REPLACED WITH A NEW LOWER PERITONEAL DIALYSIS (PD) CATHETER.

  Patient problems: Injury

  MAUDE report 7464642 ↗